Cyberknife After Breast Conservative Surgery

NCT ID: NCT02896322

Last Updated: 2016-09-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2018-06-30

Brief Summary

Accelerated partial breast irradiation with CyberKnife (CK-APBI) is a promising innovative approach for early breast cancer after conservative surgery, for addressing the need of a radiotherapy target only to the surgical cavity in selected patients, exceeding the limits of other PBI/APBI.

Detailed Description

The large majority of local recurrences in breast cancer after breast conserving treatment are close to the original tumor site. This evidence suggested to restrict the radiotherapy target to the surgical cavity in selected patients. Consequently, shorter fractionation strategies focused only on tumor bed with a small cuff of surrounding subclinical disease, i.e. accelerated partial breast irradiation (APBI), were developed. Stereotactic radiotherapy was thought, consisting of a short course of intense treatment focused on the target tissue. There is very little experience with CiberKnife for early breast cancer until now.

This study is a prospective non-randomized study designed to assess the acute, sub-acute, late toxicity, cosmesis and globally the feasibility of CyberKnife (CK-APBI). From June 2013 to June 2018 we are going to enroll 80 patients considered eligible for the present study. All patients will be followed for at least 2 years. A first enrollment of 20-25 patients is scheduled as first assessment.

Breast magnetic resonance imaging (MRI) will be aided to mammography and ultrasound examination for confirming the best selection of patients.

For the assessment of acute toxicity, cosmetic results by three different observers (physician, patient, external observer), medium term and late toxicity, patients were evaluated and the results recorded immediately before and after radiotherapy, then after 1 month, three, six, nine, and twelve, and twenty-four months. The toxicity will be correlated to the main radiotherapy treatment dosimetry and delivery recorded.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cyberknife

APBI with cyberknife after breast conserving surgery in breast cancer

Group Type: EXPERIMENTAL

Partial breast irradiation with cyberknife

Intervention Type: RADIATION

Interventions

Partial breast irradiation with cyberknife

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• Patients were ≥45 years of age with stage I-IIA histologically confirmed breast carcinoma, with tumor-free (at least 2 mm or more) inked histologic margins at surgical resection.

Exclusion Criteria

• Invasive lobular or multicentric carcinoma;
• Extensive associated non-invasive ductal carcinoma (synchronous or previous); peritumoral vascular invasion (>3 vessels);
• BRCA mutation carriers,
• >4 involved axillary lymph nodes,
• Distant metastasis,
• Non-epithelial malignancies of the breast,
• Synchronous contralateral invasive carcinoma,
• Paget disease,
• History of previous malignancy (except non-melanoma skin cancers and in situ oral cavity and cervix carcinoma);

• Minimum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laura Lozza, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Locations

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Lombardy, Italy

Site Status: RECRUITING

Fondazione IRCCS Istituto Neurologico C. Besta

Milan, Lombardy, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Roberto Agresti, MD

Role: CONTACT

roberto.agresti@istitutotumori.mi.it

02-2390 ext. 2168

Laura Fariselli, MD

Role: CONTACT

lfariselli@istituto-besta.it

Facility Contacts

Roberto Agresti, MD

Role: primary

roberto.agresti@istitutotumori.mi.it

02-2390 ext. 2168

Laura Lozza, MD

Role: backup

laura.lozza@istitutotumori.mi.it

02-2390 ext. 2799

Laura Fariselli, MD

Role: primary

Laura.Fariselli@istituto-besta.it

References

Lozza L, Fariselli L, Sandri M, Rampa M, Pinzi V, De Santis MC, Franceschini M, Trecate G, Maugeri I, Fumagalli L, Bonfantini F, Bianchi G, Pignoli E, De Martin E, Agresti R. Partial breast irradiation with CyberKnife after breast conserving surgery: a pilot study in early breast cancer. Radiat Oncol. 2018 Mar 23;13(1):49. doi: 10.1186/s13014-018-0991-4.

Reference Type: DERIVED

PMID: 29566762 (View on PubMed)

Other Identifiers

INT 109/12

Identifier Type: -

Identifier Source: org_study_id